In controlled clinical trials, single doses of 20 mg and 40 mg were effective
for the acute treatment of migraine in adults. A greater proportion of patients
had a response following a 40 mg dose than following a 20 mg dose (see CLINICAL
STUDIES). Individuals may vary in response to doses of RELPAX Tablets. The
choice of dose should therefore be made on an individual basis. An 80 mg
dose, although also effective, was associated with an increased incidence
of adverse events. Therefore, the maximum recommended single dose is 40
mg.
If after the initial dose, headache improves but then returns, a repeat
dose may be beneficial. If a second dose is required, it should be taken
at least 2 hours after the initial dose. If the initial dose is ineffective,
controlled clinical trials have not shown a benefit of a second dose to
treat the same attack. The maximum daily dose should not exceed 80 mg.
The safety of treating an average of more than 3 headaches in a 30-day
period has not been established.
CYP3A4 Inhibitors: Eletriptan is metabolized by the CYP3A4 enzyme.
Eletriptan should not be used within at least 72 hours of treatment with
the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone,
troleandomycin, clarithromycin, ritonavir and nelfinavir. Eletriptan should
not be used within 72 hours with drugs that have demonstrated potent CYP3A4
inhibition and have this potent effect described in the CONTRAINDICATIONS,
WARNINGS or PRECAUTIONS sections of their labeling (see WARNINGS and CLINICAL
PHARMACOLOGY: Drug Interactions).
Hepatic Impairment: The drug should not be given to patients with
severe hepatic impairment since the effect of severe hepatic impairment
on eletriptan metabolism was not evaluated. No dose adjustment is necessary
in mild to moderate impairment (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS
and PRECAUTIONS).